We are fully experienced to develop turnover packages that comply with FDA GMP, ISO and other regulatory requirements. We provide comprehensive GMP documentation throughout every phase of our design, build and installation process to ensure quality control both for compliance as well as to improve client’s internal processes. We have hands-on experience in the validation of utilities, computers, process, equipment, instruments, automation systems and much more for the pharmaceutical and biotech industries

Validation Documentation:

• Design Documentation
• Traceability Matrix
• User Requirements Specifications (URS)
• Hardware Design Specification (HDS)
• Software Design Specification (SDS)
• Mechanical Drawings, Electrical Schematic, Pneumatic Schematic, and Software Source Code
• Operating Manual (w/ troubleshooting, spare parts, PM, etc.)
• OEM Manuals
• Data Reporting & Database Integration

Project Documentation

• Project Gantt Charts
• Project Action Items Lists

Testing & Qualification

• Factory Acceptance Testing (FAT)
• Site Acceptance Testing (SAT)
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)